N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company developing Nuvec®, a novel delivery system for vaccines and cancer treatments, announces that at its annual general meeting, being held later today, Nigel Theobald, Chief Executive Officer, will provide the following update on the timings for the recently announced repeat of the in vivo work at University of Queensland.
As previously announced, studies to date have demonstrated that Nuvec® consistently promotes transfection in in vitro experiments using both DNA and messenger RNA (mRNA) plasmids. The primary in vivo study conducted by UQ also demonstrated that Nuvec® is effective in vivo, as a measurable antibody response was achieved using Ovalbumin plasmid DNA (OVA pDNA).
Evaluation of subsequent in vivo studies conducted by other laboratories indicated that the preparation and loading of Nuvec® with DNA or mRNA differed to the methods used by UQ in the primary study. By returning to UQ to repeat the successful in vivo work using OVA pDNA, the Company expects to affirm the precise loading protocol and methodology and to properly document the process for successful technology transfer to other CROs and partners. This will provide the benchmark conditions to be used to evaluate the delivery of antigen by Nuvec® in a well characterised oncology efficacy model.
The relevant committees at UQ have now approved the commencement of the studies and, with this approval, the experiments are expected to start on 21 June 2019. UQ has advised that results are expected to be available in approximately two months. The repeat work at UQ will be monitored and recorded by N4’s Head of CMC Programme Development, Dr Allan Hey.
The Board is pleased to now have greater clarity on the timing of the next UQ work and believe a properly documented protocol, by repeating the earlier successful study, will enable the Company to accelerate other studies. The Company remains well funded to achieve this objective.
The Directors of the Company are mindful that Nuvec® will not work first time for every application and in every experiment. There are many variables to consider in any pre-clinical experiment, such as the antigen itself, how to load it onto Nuvec®, the dose, concentration of Nuvec® and injection volume and understanding how these factors can cause inconsistency is an important part of Nuvec®’s development. The Directors remain confident that Nuvec® has the potential to be an innovative and effective delivery system in the field of nucleic acid vaccines and therapeutics.”